BOSTON, Massachusetts—Physicians need to be more vigilant about prescribing proton pump inhibitors (PPIs) to their arthritis patients who take traditional nonsteroidal anti-inflammatory drugs (NSAIDs), because the number of serious gastrointestinal (GI) complications is on the rise since the great COX-2 debacle of 2004. Gurkirpal Singh, MD, an adjunct clinical professor of medicine, division of gastroenterology and hepatology at Stanford University School of Medicine in Palo Alto, California, reported these findings at the annual meeting of the American College of Rheumatology in Boston.

"An increasing number of elderly users of NSAIDs are again being left without appropriate gastroprotection resulting in an impending public health disaster," Dr. Singh said. Going forward, "[physicians] can either increase the use of PPIs or use the COX-2s for gastroprotection."

The gastroprotection gap increased twofold reaching 35% in 2005, following a decline in the use of COX-2 drugs without a commensurate increase in other gastroprotective therapies such as PPIs or misoprostol. As this gap widened, there was a 21% increase in serious GI complications in 2005.

"In 2005, COX-2 use declined by almost 50% and the use of PPIs tripled but this did not compensate for the decline in COX-2 drugs," he said.

The new study comprised arthritis patients >65 years of age enrolled from 1997 to 2000 in MediCal, the Medicaid program for California; all patients were treated with NSAIDs for at least 30 days; NSAID prescriptions totaled 4,474,074 in that time period. Researchers then calculated the rate of hospitalizations and/or emergency room visits for complicated gastric and duodenal ulcers per 100,000 NSAID prescriptions.

Widening gap follows years of decline

In 2004, just 14% of patients were not receiving gastroprotection. By contrast, 79% of patients were not receiving gastroprotection in 1997, the study showed. This decline coincided with the eradication of Helicobacter pylori infection as well as better medical care including the growing use of COX-2 blockers.

"It started getting smaller and as COX-2 inhibitors were introduced, the gap became even smaller," Dr. Singh said.

In fact, the rate of serious GI complications dropped from 682 per 100,000 prescriptions in 1997 to 357 per 100,000 in 2004 (P <.0001). The sharpest decline per 100,000 prescriptions was seen from 1999 to 2000 when there were 570 GI complications dropping to 423 GI complications, respectively. This drop corresponded with a large decline in the gastroprotection gap from 55.6% in 1999 to 25.2% in 2000.

 Decreased Gastroprotection and Increase in Serious GI Complications

Year	COX-2 inhibitors (%)	PPI (%)	Misoprostol (%)	Gastroprotection gap (%)	Serious ulcer complications (per 100,000 NSAID prescriptions)
1997	0	11.3	9.6	79.1	682.3
1998	0	13.4	9.9	76.7	635.7
1999	30.6	8.7	5	55.6	579.5
2000	69	4.4	1.5	25.2	423.2
2001	76.6	4	0.8	18.7	390.6
2002	77.6	4.8	0.6	17.1	409.1
2003	80	5.1	0.4	14.5	380.6
2004	79.1	6.4	0.5	13.9	357.2
2005	43.1	20.5	1.6	34.8	433.7

Adapted from Singh G et al.¹

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